Suture packages are designed to present sutures to the user in a clean, sterile and undamaged form, in a convenient and readily accessible manner, and in such a fashion that tangling or damage of the suture does not occur during removal from the package. The requirement to avoid tangling during removal has heretofore been accomplished by arranging the sutures in ordered and precise configurations within the package. This typically takes the form of placing a suture into a narrow, confining channel such as described in U.S. Pat. No. 3,338,401, or by arranging the suture into a precise configuration (generally with a winding technique) so that it cannot cross over itself during removal, as described in U.S. Pat. No. 4,496,045.
U.S. Pat. No. 3,338,401 also describes the use of a stream of air to carry the suture into the narrow, confining channel of the package. This package incorporates an entrance port for the suture and the carrying stream of air. A small vent is provided at the opposite end of the narrow confining channel to allow the stream of air to exhaust from the package.
While these previous packages function well in terms of product protection, sterility, convenience and avoidance of tangling, drawbacks exist in terms of the amount of space and materials required for these packages. In addition, these packages are often complex, relatively expensive and may require sophisticated equipment and/or excessive labor to perform the packaging operation.
It is readily apparent that the use of narrow, confining channels within the package or the use of precise, controlled configurations will require significant use of space and packaging materials. If multiple sutures are contained within the same package even more space and material is required. The space requirement can be seen to be a substantial problem when the quantity of sutures maintained in a typical large hospital inventory is taken into account. Likewise, these packages contribute significantly to hospital waste disposal problems.
The present invention allows the suture to be packaged and stored within a simple cavity in a configuration sequentially ordered along the suture withdrawal path but otherwise random. The cavity is dimensionally configured, that is of appropriate length, width and depth, to allow the suture to lie within the package in this sequentially ordered but otherwise random configuration. The cavity dimensions, particularly width, do not allow the suture to lie in an ordered or controlled configuration. After sequential loading of the suture into the cavity through the housing port, the suture package of the present invention allows a substantial length of suture material to be packaged within a small volume of space. Multiple sutures can be packaged within a small space by providing multiple cavities within a single package or, for single-armed sutures, by placing multiple sutures into a single cavity.
The smallest possible suture package configuration is that of a package containing a single suture. The package of the present invention having a single cavity containing a single suture can be made smaller than can be reliably held and opened by gloved human hands under operating room conditions. It is apparent that with the package of the present invention the size of a suture package has achieved the minimum practical limit.
The simplicity of the package of the present invention reduces the complexity of the packaging operation and the time required for that operation. The result can be a less expensive package that may require less space than previous packages, yet is at least equally as functional as previous packages.
It has been previously known to store ropes within cavities in a fashion similar to the suture package of the present invention. For example, ropes for whitewater rescue are stored within bags by inserting the first end of a rope into a bag and continuing to feed the length of rope into the bag until only the second end remains outside. The length of rope is thus stacked or piled within the bag in a configuration sequentially ordered along the withdrawal path but otherwise random. Ropes contained in such a fashion will pay out from the bag quickly and reliably without tangling.
For the purposes of this invention, a cavity is defined as a three dimensional space surrounded by a housing. The housing may have openings such as vents or ports. The phrase "in a configuration sequentially ordered along the suture withdrawal path but otherwise random" is herein meant to describe the arrangement of the suture within the package cavity wherein it is stored in the form of stacks or piles in a random configuration from which it is able to be withdrawn sequentially from the cavity via the port quickly and tangle-free in the fashion of rope withdrawn from the above described rope bag. The random configuration in which the suture lies within the cavity is the result of the suture having been fed sequentially through the port and into the cavity. As the suture is fed sequentially into the cavity, it piles or stacks into layer upon layer, with some overlap or crossover between layers. This imprecise stacking or layering is herein defined as a random configuration.